The National Library of Medicine organized a two-day conference last month to highlight best practices for enhancing reproducibility of scientific research through increased rigor and transparency in reporting.
“Consequential Clinical Research: Accelerating Continuous Improvement” included 14 sessions covering such topics as enhancing the quality of clinical research studies, achieving trustworthy results, increasing transparency, and delivering benefits to patients. The conference was a follow-up to a conference in 2016 that focused on irreproducible results in preclinical research.
NLM Director Patricia Flatley Brennan, RN, PhD, welcomed the group on behalf of the staff of NLM who work to ensure that consequential clinical research is identifiable, accessible, and distributed around the world.
“Often consequential or reproducible results focus on the end of the trail of clinical studies,” she said. “As we look to reproducibility and determining consequences, we need a broad view. There are many perspectives and values in clinical research. And what constitutes ‘consequential’ may be informed by one’s perspective and one’s ability to act on knowledge and participate in that knowledge.”
She urged the group to consider the needs of society, especially as we turn to a data-driven era. “Most of us are familiar with our obligations to our scientific partners and our participants, and perhaps even to the community at large,” Dr. Brennan said. “We need to be mindful that our responsibility for consequential research extends to society.”
The keynote address, “What Makes Clinical Studies Consequential and Valuable?,” was delivered by Carolyn Clancy, MD, deputy undersecretary for Health for Organizational Excellence, Veterans Health Administration. She spoke about Dr. Andrew Balas’ work that showed the time from initial research funding to that research affecting patients is 17 years on average, a time frame that must be accelerated.
“The vision of PubMed is phenomenal and, in fact, all trials should be preceded by a clinical review,” Clancy said. “We do need to be more cautious, and there is a need for consistent analysis of meta research. Data is everywhere—in theory, this should be a wonderful time for clinical research.”
Deborah A. Zarin, MD, director of NLM’s ClinicalTrials.gov, indicated that society only permits research in humans when the knowledge produced can be applied generally for future patients and can address important questions that cannot be answered using existing biomedical knowledge. The studies must be consequential. She said that research using data from ClinicalTrials.gov suggests the current clinical research enterprise landscape consists of a mix of consequential and non-consequential studies. To reach the societal goal of increasing the proportion of consequential trials, Zarin said that rules and regulations alone are insufficient and urged all stakeholders to take responsibility for applying and incentivizing quality improvement as a cultural norm.
Other speakers included medical researchers from Harvard University, University of Texas MD Anderson Cancer Center, and private industry, as well as patient advocates.
The executive managing editor of JAMA: The Journal of the American Medical Association, Annette Flanagin, was among many of the attendees who praised the quality of the discussions and noted NLM is unique in its ability to bring together such viewpoints.
Balas, whose research was cited by Clancy, served as a co-chair of the conference planning committee. He is a professor and dean of the College of Allied Health Sciences and director of the Biomedical Research Innovation Laboratory at Augusta University in Georgia.
Joining NLM as co-sponsors of the conference were the Friends of the National Library of Medicine and Research!America.
By Adam Shapiro, guest writer for NLM in Focus